Observational, Non-interventional Biomarker and Endotyping Study

N/ANot Yet RecruitingNCT07675265

Prenosis, Inc.1,200 enrolled

Overview

The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop unsupervised, therapy-specific treatment-prediction algorithms over a 24 month period.

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * ARDS Diagnosis (New Global Definition of ARDS) * Timing: Acute onset within 7 days * Radiology: Bilateral pulmonary opacities * Hypoxia: Non-intubated ARDS: PaO2:FIO2\<300mmHg or SpO2:FIO2\<315 (if SpO2\<97%) on HFNO with flow of \>30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure; or Intubated ARDS: PaO2:FIO2\<300 mm Hg or SpO2:FIO2\<315 (if SpO2\<97%) * ICU admission * Enrolled within 72 hours of meeting inclusion criteria Exclusion Criteria: • Primary cardiogenic pulmonary edema

Outcomes

Primary Outcomes

Number of Participants with an ARDS Diagnosis

Adults with clinically defined ARDS receiving ICU-level care

Time frame: from enrollment to 28-day in-hospital mortality

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.